Patch pump training device

ABSTRACT

Described are methods and systems to train a user in the proper operation of a manual patch pump to ensure that the user can attach the patch pump to a suitable location on the skin of the user and actuate the pump correctly in accordance with a prescribed dosing schedule or a self-calculated dosing schedule.

BACKGROUND

Diabetes mellitus is a chronic metabolic disorder caused by an inabilityof the pancreas to produce sufficient amounts of the hormone drug sothat the metabolism is unable to provide for the proper absorption ofsugar and starch. This failure leads to hyperglycemia, i.e. the presenceof an excessive amount of analyte within the blood plasma. Persistenthyperglycemia has been associated with a variety of serious symptoms andlife threatening long term complications such as dehydration,ketoacidosis, diabetic coma, cardiovascular diseases, chronic renalfailure, retinal damage and nerve damages with the risk of amputation ofextremities. Because healing is not yet possible, a permanent therapy isnecessary which provides constant glycemic control in order to alwaysmaintain the level of blood analyte within normal limits. Such glycemiccontrol is achieved by regularly supplying external drug to the body ofthe patient to thereby reduce the elevated levels of blood analyte.

External drug was commonly administered by means of multiple, dailyinjections of a mixture of rapid and intermediate acting drug via ahypodermic syringe. While this treatment does not require the frequentestimation of blood analyte, it has been found that the degree ofglycemic control achievable in this way is suboptimal because thedelivery is unlike physiological drug production, according to whichdrug enters the bloodstream at a lower rate and over a more extendedperiod of time. Improved glycemic control may be achieved by theso-called intensive drug therapy which is based on multiple dailyinjections, including one or two injections per day of long acting drugfor providing basal drug and additional injections of rapidly actingdrug before each meal in an amount proportional to the size of the meal.Although traditional syringes have at least partly been replaced by drugpens, the frequent injections are nevertheless very inconvenient for thepatient, particularly those who are incapable of reliablyself-administering injections.

Substantial improvements in diabetes therapy have been achieved by thedevelopment of the drug delivery device, relieving the patient of theneed for syringes or drug pens and the administration of multiple, dailyinjections. The drug delivery device allows for the delivery of drug ina manner that bears greater similarity to the naturally occurringphysiological processes and can be controlled to follow standard orindividually modified protocols to give the patient better glycemiccontrol.

In addition delivery directly into the intraperitoneal space orintravenously can be achieved by drug delivery devices. Drug deliverydevices can be constructed as an implantable device for subcutaneousarrangement or can be constructed as an external device with an infusionset for subcutaneous infusion to the patient via the transcutaneousinsertion of a catheter, cannula or a transdermal drug transport such asthrough a patch. External drug delivery devices are mounted on clothing,hidden beneath or inside clothing, or mounted on the body and aregenerally controlled via a user interface built-in to the device or on aseparate remote device.

In recent years, parties have devised systems and devices for trainingoperators on medical devices. For example, US Patent ApplicationPublication No. 2002/0001794 to Melker et al., shows and describes ageneric medical device training system which utilizes a series ofsequential lessons for proper operation of the devices. US PatentApplication No. 2004/0152065 to Witkowski shows a simulated device toeducate users on the operation of a blood test meter and test strip.These exemplary systems have shortcomings in that neither of Melker norWitkowski allow for training in actual field conditions. The training isdone in what is believed to be in unrealistic conditions using a generichandheld palm type computer (i.e., Melker) or a demonstration type model(i.e., Witkowski). Moreover, the training on Melker and Witkowski arepredetermined such that the training cannot be customized for the user'sparticular health conditions.

SUMMARY OF THE DISCLOSURE

Applicants have devised techniques and methods to overcome theshortcomings identified in the art.

In one aspect, a patch type drug delivery pump training system isprovided. The system includes a trainer device and a monitor device. Thetrainer device includes a base configured to be attached to a user'sepidermis; a housing attached to the base, the housing having dosingactuator; a processor coupled to a memory, clock and dosing switchesconnected to the dosing actuators, the dosing switches configured toindicate dosing events whenever the dosing actuators have been actuatedand such dosing events stored in the memory. The monitor device isdisposed apart from the trainer device, the monitor device beingconfigured to receive data from the memory of the trainer device. Thedata includes dosing events and time of each event so that the monitordevice provides an indication of whether the user has actuated thedosing switches in accordance with a dosing plan stored in one of themonitor device or the trainer device.

In another aspect, a method of training a user on the use of an actualpatch type drug delivery pump is provided. The actual patch pump isconfigured to deliver a drug stored in the pump body. The method can beachieved by: providing a dosing schedule of the drug to the user;providing a trainer device to the user, the device having a dummy orsimulated housing and dummy or simulated actuators similar in shape andsize as the actual patch type drug delivery pump, the dummy or simulatedhousing containing a processor and memory coupled to respective switchesof the dummy or simulated actuators; furnishing the user with a dosingschedule; actuating the dummy or simulated actuators; recordingactivation of the switches for the dummy or simulated actuators and thetime at which such activation occurred into the memory to provide arecord of training dosage events; and outputting the record to providefor a comparison between training usages of the trainer device ascompared to the dosing schedule.

In yet a further method, a method of training a user on the use of anactual patch type drug delivery pump is provided. The actual patch pumpis configured to deliver a drug stored in the pump body. The method canbe achieved by providing a dosing schedule of the drug to the user;providing a trainer device to the user, the device having a dummy orsimulated housing and dummy or simulated actuators similar in shape andsize as the actual patch type drug delivery pump, the dummy or simulatedhousing containing a processor and memory coupled to respective switchesof the dummy or simulated actuators; annunciating to the user the dosingschedule; recording activation of the switches for the dummy orsimulated actuators and the time at which such activation occurred intothe memory to provide a record of training dosage events; and outputtingthe record to provide for a comparison between training usages of thetrainer device as compared to the dosing schedule.

And for these aspects, the following features may also be utilized invarious combinations with these previously disclosed aspects: themonitor device may include a smartphone programmed to receive datatransmitted by the trainer device by a suitable wireless protocol; thewireless protocol is selected from one of a Bluetooth, WiFi, RFID, or aNear-Field-communication protocol; the trainer device further mayinclude a power source connected to the processor of the trainer device;the trainer further may include: an audio output connected to theprocessor to provide the indication in audible form; a visual outputconnected to the processor to provide the indication in visual form; anda wireless transmitter connected to the processor to transmit the datato the monitor device; the base further may include at least one sensorconfigured to determine a suitable location for a drug delivery pumpbased on the impedance of the epidermis at which the housing is attachedthereto; the sensor may include at least two electrodes configured tocontact the epidermis and transmit an alternating signal between the atleast two electrodes; the sensor may include at least two electrodesconfigured to measure capacitance of the epidermis at a location ofattachment of the trainer device; the method may further includecomparing a time at which actuating of the dummy actuators is takingplace and the time prescribed by the dosing schedule; in the event atwhich the time prescribed in the dosing schedule is not within apredetermined time period of the actuating step, recording noncomplianceof the dosing schedule in the memory; or in the event at which theprescribed time for dosing is within a predetermined time period of theactuating step, recording a compliance with the dosing schedule in thememory. Alternatively, the recording of an error may includeannunciating a negative feedback to the user at the time the recordingis made; the recording of the compliance may include annunciating of apositive feedback to the user at the time the recording is made.; theoutputting may include displaying a graphical representation of time atwhich one or more actuations have occurred and the prescribed dose atthe prescribed time; the predetermined time period may include any timeperiod from about 10 minutes to about 60 minutes.

In the aforementioned aspects of the disclosure, the steps of thedescribed method may be performed by an electronic circuit or aprocessor. These steps may also be implemented as executableinstructions stored on a computer readable medium; the instructions,when executed by a computer may perform the steps of any one of theaforementioned methods.

In additional aspects of the disclosure, there are computer readablemedia, each medium comprising executable instructions, which, whenexecuted by a computer, perform the steps of any one of theaforementioned methods.

In additional aspects of the disclosure, there are devices, such as testmeters or analyte testing devices, each device or meter comprising anelectronic circuit or processor configured to perform the steps of anyone of the aforementioned methods.

These and other embodiments, features and advantages will becomeapparent to those skilled in the art when taken with reference to thefollowing more detailed description of various exemplary embodiments ofthe invention in conjunction with the accompanying drawings that arefirst briefly described.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and constitutepart of this specification, illustrate presently preferred embodimentsof the invention, and, together with the general description given aboveand the detailed description given below, serve to explain features ofthe invention (wherein like numerals represent like elements).

FIG. 1 illustrates an exemplary embodiment of the training system for apatch pump.

FIG. 2 illustrates the training device of FIG. 1.

FIG. 3 illustrates a plan view of the underside of the training devicein FIG. 2 to show the sensors for the adhesive patch.

FIG. 4 illustrates a system architecture of the components disposedinside the training device of FIG. 1.

FIG. 5 illustrates an exemplary graphical report of the user'sperformance in real-life conditions.

MODES FOR CARRYING OUT THE INVENTION

The following detailed description should be read with reference to thedrawings, in which like elements in different drawings are identicallynumbered. The drawings, which are not necessarily to scale, depictselected embodiments and are not intended to limit the scope of theinvention. The detailed description illustrates by way of example, notby way of limitation, the principles of the invention. This descriptionwill clearly enable one skilled in the art to make and use theinvention, and describes several embodiments, adaptations, variations,alternatives and uses of the invention, including what is presentlybelieved to be the best mode of carrying out the invention.

As used herein, the terms “about” or “approximately” for any numericalvalues or ranges indicate a suitable dimensional tolerance that allowsthe part or collection of components to function for its intendedpurpose as described herein. In addition, as used herein, the terms“patient,” “host,” “user,” and “subject” refer to any human or animalsubject and are not intended to limit the systems or methods to humanuse, although use of the subject invention in a human patient representsa preferred embodiment. Furthermore, the term “user” includes not onlythe patient using a drug infusion device but also the caretakers (e.g.,parent or guardian, nursing staff or home care employee). The term“drug” may include pharmaceuticals or other chemicals that causes abiological response in the body of a user or patient. The term“annunciate” and variations on its root term indicate that anannouncement may be provided via text, audio, visual or a combination ofall modes or mediums of communication to a user.

FIG. 1 illustrates a patch pump training system 10 according to anexemplary embodiment. Patch pump training system 10 includes a patchpump trainer 100 and a remote monitor 200. Patch pump trainer 100 isconfigured to transmit and receive data to and from remote monitor 200by, for example, radio frequency communication 150. Patch pump trainer100 may also function as a stand-alone device with its own built incontroller. In one embodiment, patch pump trainer 100 is a simulatedpatch pump device and remote monitor 200 is a hand-held portable monitorsuch as, for example, a smartphone, mobile phone or a bespoke monitorand wireless communication transceiver using any suitable communicationprotocol such as for example, BlueTooth Low Power, WiFi, RFID, NFC andequivalents thereof. In such an embodiment, data transmitted from patchpump trainer 100 to a remote network directly or via a remote monitor200 may include information such as, for example, dosing events, time ofdosing events and dosage delivered or undelivered, the state of internalbattery charge, or any internal system errors. Alternatively, housingtemperature, or any sharp acceleration indicating device abuse (hardknocks) can be sensed by a sensor or a combination of sensors mounted orbuilt into the device. Also device attachment information from thecapacitive sensors are provided to indicate if the device was initiallyattached properly, or if it has come loose in operation, to name a few.Data transmitted from remote monitor 200 to patch pump trainer 100 mayinclude a dosing schedule, time and date, software update, messages tothe trainee or user regarding changes in dosing schedule, carbinformation of simulated meal intake and the like. Alternatively, theremote monitor 200 may perform other functionalities with the trainerdevice 100 such as for example, providing messages or instructions tothe user to perform other tasks such as checking for proper mounting ofthe pump.

Each of the devices 100 and 200 has a suitable micro-controller (notshown for brevity) programmed to carry out various functionalities. Forexample, a microcontroller can be in the form of a mixed signalmicroprocessor (MSP) for each of the devices 100 or 200. Such MSP maybe, for example, the Texas Instrument MSP Mode1430, as described inpatent application publication numbers US2010-0332445, andUS2008-0312512 which are incorporated by reference in their entiretyherein. The MSP Mode1430 or the pre-existing microprocessor of each ofthese devices can be configured to also perform the method described andillustrated herein.

Patch pump trainer 100 may also be configured for bi-directionalwireless communication with a remote health monitoring station 206through, for example, a wireless communication network 204. Remotemonitor 200 and remote monitoring station 206 may also be configured forbi-directional wired communication through, for example, a telephoneland based communication network. Remote monitoring station 206 may beused, for example, to download upgraded software to patch pump trainer100 and to process information from patch pump trainer 100. Examples ofremote monitoring station 206 may include, but are not limited to, apersonal or networked computer, a personal digital assistant,SmartPhones, other mobile telephone, a hospital base monitoring stationor a dedicated remote clinical monitoring station.

FIG. 2 illustrates the training patch pump device 100 in a perspectiveview. The trainer device 100 includes a dummy or simulated housing 102with first dummy or simulated actuator bar 104 and second dummy orsimulated actuator bar 106. The housing 102 is mounted to a base 108which can be in the form of a flexible member with adhesive disposed onthe underside of the member for attachment to the epidermis of a user.As used herein, the term “dummy” or “simulated” is used to indicate thatthe subject component referenced as “dummy” does not have the samefunction as in the actual patch pump device, which is shown anddescribed in U.S. Pat. Nos. 7,976,500; 7,771,391; 7,976,493; 8,128,597;7,927,306; 8,062,256; 8,128,596 and in US Patent Application PublicationNos. 2009/0088694; 2009/0156989; 2009/0326455; 2009/088690;2011/0112484, all of these noted disclosures are hereby incorporated byreference into this application as if fully set forth herein.

FIG. 3 illustrates a plan view of the underside of housing 102 with basemember 108. The based member 108 can be provided with a suitableadhesive for attachment to the skin of the user. The underside ofhousing 102 can be provided with at least one resistance or impedancesensor(s). In the preferred embodiments, there are four sensors 110 a,110 b, 110 c, and 110 d provided to allow the sensors to determine ifthe location for placement of the dummy patch pump 100 is at theappropriate location with sufficient interstitial tissues for deliveryof drugs had the device 100 been an actual drug delivery device. Each ofthe sensors can include at least one electrode to allow the electrode todrive at least one alternating signal into the epidermis for sensing ofthe differential signal returning from the epidermis. Alternatively, onesensor (e.g., 110 a) may drive at least one alternating signal into theepidermis so that a determination of whether the device was mounted tothe skin by comparing the signals to see if the device is in firmcontact with the skin. The electrode(s) of each sensor may be configuredto pierce the skin but without extending into the dermis layercontaining the blood vessels or the nerves and thereby would bevirtually painless. Alternatively, the electrodes may not need to piercethe skin to detect surface capacitance. That is, the electrodes may notneed to be in contact with the skin by utilizing the projectedcapacitance technique similar to touchscreen technology. The sensors canoperate to measure impedance with signal frequencies from about 5 kHz toabout 1 MHz. Where the impedance measured by the sensor is high ascompared to a predetermined threshold, the processor would indicate tothe user that the site for adhering could be inappropriate or that thepatch pump is not fully attached to the epidermis. Alternatively, thesensors can be capacitive type sensors using DC signals. Where thecapacitance measured by the sensors is low, the processor wouldindicate, as before, that the patch pump is not fully attached to thesite due to the poor contact of the sensors with the skin.

Although keys, keypads, speaker, piezo-electric transducer, and alow-cost low powered display are not shown in the Figures for brevity,such components are implemented with the device as provided in thesystem architecture shown in FIG. 4.

FIG. 4 illustrates the architecture of the trainer device 100. Intrainer device 100, the electrical components may include a centralprocessing unit 310 (e.g., microprocessor or microcontroller) and memorystorage 314 for storing control programs and operation data. A radiofrequency transceiver module 312 is provided for sending and receivingcommunication signals (i.e., messages, data, and information) to/fromremote monitor 200. A display 318 can be provided for operationalinformation to the user. A plurality of navigational keypad 308 (detailsnot shown) for the user to input information. An alarm or voice box 316(e.g., visual, auditory or tactile) can be connected to the processor310 for immediate feedback to the user by annunciating negative orpositive feedbacks. As used here, the term “annunciate” or“annunciating” and variations on the root term indicate that anannouncement may be provided via text, audio, visual or a combination ofall modes of communication. Alternatively, a simple vibrator can also beused in place of the voice box 316. Respective switches 302 can becoupled to the dummy actuator 106 so that upon actuation of dummyactuator 106, one or both of the switches 302 close a detection circuit,thereby indicating to the processing unit 310 that the user hasconducted a dosing event for the purpose of training (even though thereis no dosing taking place). Because the actual patch pump requires bothdosing actuators to be actuated at about the same time for a properdosing, the processor unit will recognize if only one of the two buttonshas been actuated. In such case, the processor would detect that theuser has improperly actuated the dosing buttons and store a record ofsuch improper dosing. The switches 302 can be displacement sensitivesuch that the processing unit 310 will be able to recognize if the userhas fully depressed each of the dummy actuator bars 104 and 106. In theevent the user has not fully compressed one or both of the actuator bars104 and 106 (which would be indicated by an audible click on the actualpatch pump and necessary for the actual pump to deliver the correctdosage), the processing unit 310 will recognize this partialdisplacement of the actuator bars 104 and 106 as an improper actuationand record such event as an improper dosing event. A clock 304 isconnected to the processing unit 310 so that the time at which a dosingevent occur (and which event may be flagged or tagged as proper orimproper).

It is noted that while the device 100 is shown with a battery powersupply, the device 100 can be a Near-Field-Communication (“NFC”) enableddevice so that its functionalities can be powered by the NFC equippedmonitor 200 (or an NFC enabled SmartPhone) with the NFC enabled monitorclose by.

In operation, the user or the health-care-provider (“HCP”) would attachthe trainer device 100 onto an appropriate location on the outer skinlayer of the user. The trainer device 100 can be attached directly ifthe patch pump has a user insertable needle and cannula. Alternatively,the device can be used with an inserter device such as that shown anddescribed in U.S. Pat. No. 7,713,258; 7,931,621; or US PatentApplication Publication No. 2007/0282269, which are hereby incorporatedby reference as if fully set forth herein. Where the trainer device 100includes sensors 110 a-110 d, the sensors could indicate to the user (ortrainee) via the voicebox or display whether the device has beenattached evenly across the epidermis. Next, the user is provided with aschedule or directions to begin actuation of the trainer device as ifinsulin would actually be given. Over the course of several days, theHCP would monitor the trainer device 100 remotely over the network 204using a monitor 200 provided to the user. Alternatively, a softwareprogram can be loaded into a SmartPhone (e.g., iPhone or Android) foruse with a Near-Field wireless built into both the trainer device 100and the SmartPhone. Data collected from the trainer device 100 can beused by the monitor device 200 (or a SmartPhone) would be immediatelycommunicated to the user via the monitor 200. Data collected over 12 ormore hours could be used to show whether the user is in compliance witha dosing schedule configured into the monitor 200 (or SmartPhone) or theuser's own calculation for boluses to be given over a period of time.The user's calculated boluses can be imported or entered into the memoryof the device 100 or the monitor 200. The HCP's prescribed dosingschedule or the user's own calculated dosing schedule would then be usedto determine if correct usage of the trainer device 100 has beenfollowed.

In particular, applicants have devised a method to train users onoperation of a patch pump. The method can be achieved by: providing adosing schedule of the drug to the user. The dosing schedule can be onegenerated by the HCP or by the user using his or her own boluscalculation. Thereafter, a trainer device is provided to the user andthe dosing schedule can be entered via monitor 200 or directly viaNear-Field communication or any other short range communication RF suchas BlueTooth; BTLE, WiFi, or a proprietary RF with the HCP's computer206. The user, following the schedule, would actuate the dummyactuators. This would cause the processor to record the activation ofthe switches for the dummy actuators and the time at which suchactivation occurred into the memory to provide a record of trainingdosage events. The device 100 can output the record directly to the uservia the voicebox or display or to the monitor 200. This would providefor a comparison between training usages of the trainer device ascompared to the dosing schedule. In this comparison, the processor canbe programmed to compare a time at which actuating of the dummyactuators is taking place and the time prescribed by the dosing schedule(which can be prescribed by the HCP or generated by the user's owncalculation). In the event at which the time prescribed in the dosingschedule is not within a predetermined time period (e.g., from about 10to about 30 minutes) of the actuating step, the processor can record thenoncompliance of the dosing schedule in the memory. On the other hand,in the event at which the prescribed time for dosing is within thepredetermined time (e.g., from about 10 to about 30 minutes) of theactuating step, the system would record a compliance with the dosingschedule in the memory.

In the operational example above, the monitor 200 could provide agraphical presentation in the display, shown here in FIG. 5, of when theuser has been in compliance with the prescribed dosing schedule (in theform of a check mark or a suitable indicia or icon) or not in compliance(in the form of an X or a suitable indicia or icon).

As shown in FIG. 5, the user has been prescribed by the HCP or thetrainer device 100 has been programmed with a schedule 500 for a periodof 18 hours (e.g., during waking hours). In this schedule 500, a firstunit of insulin (or one squeeze of the dummy actuator bars 104 and 106on the trainer device 100) is to be given a 6 AM, with 2 units at 9 AMand zero units at noon. At 3 PM, 3 units (or three squeezes of theactuator bars 104 and 106) are to be given with 3 units again at 6 PMand 1 unit at 9 PM. A HCP, or even the user, reviewing the datadisplayed would immediately see that the user carried out an appropriatedosing at 502, 504, 508, and 512 (noted by check mark “√”) but gave aninappropriate dosages at 12 PM (“X” noted 506) and again at 6 PM (Xnoted at 510).

Instead of reviewing the user's dosing pattern, the device 100 or themonitor 200 could immediately provide feedback to the user withappropriate annunciation of negative feedback where the user has usedthe device incorrectly. On the other hand, the device 100 or monitor 200can also provide positive feedback immediately after the user hasoperated the device 100 correctly. Both the negative and positivefeedbacks provide “in the moment” training such that when the user isusing the actual fully functioning patch pump, the user would use suchpump correctly due to the prior training provided by device 100.

In yet another scenario, the trainer device 100 can itself provide testscenarios to the user. For example, the trainer device 100 (or monitor200) can provide a series of voice prompts for doses to be administeredby the user. In these sequences, a trainer device would be provided tothe user. As before, the device has a dummy housing and dummy actuatorssimilar in shape and size as the actual patch type drug delivery pumpthat contains a processor and memory coupled to respective switches ofthe dummy actuators. In use, the device would annunciate to the user asequence of actuation steps within a predetermined time period dosingschedule. The user is expected to follow the annunciated instructionactuate the dummy actuators in the prescribed sequence. The processorwould record the activation of the switches for the dummy actuators andthe time at which such activation occurred into the memory to provide arecord of training dosage events. Once the annunciated sequences havebeen completed (typically from 10 to 60 minutes), the device wouldoutput the record (directly to the user or the HCP) to provide for acomparison between training usages of the trainer device as compared tothe dosing schedule.

The duration of such type of short test sequence can be from about 10minutes to 60 minutes and preferably less than one hour and mostpreferably less than 30 minutes. At the end of the series of trainingprompts, the device can store the user's success versus failure scorewhich can be reported immediately to the user or to the HCP via a directtransmission from device 100 directly to the HCP (or from device 100 tomonitor 200 then from monitor 200 to the HCP) via network 204 to theHCP's computer 206 or mobile computer (e.g., laptop or SmartPhone).Alternatively, the test sequences can be conducted in the presence ofthe HCP or training operator to ensure that any questions or error canbe addressed immediately.

While the invention has been described in terms of particular variationsand illustrative figures, those of ordinary skill in the art willrecognize that the invention is not limited to the variations or figuresdescribed. In addition, where methods and steps described above indicatecertain events occurring in certain order, those of ordinary skill inthe art will recognize that the ordering of certain steps may bemodified and that such modifications are in accordance with thevariations of the invention. Additionally, certain of the steps may beperformed concurrently in a parallel process when possible, as well asperformed sequentially as described above. Therefore, to the extentthere are variations of the invention, which are within the spirit ofthe disclosure or equivalent to the inventions found in the claims, itis the intent that this patent will cover those variations as well.

1.-8. (canceled)
 9. A method of training a user on the use of an actual patch type drug delivery pump configured to deliver a drug stored in the pump body, the method comprising the steps of: providing a dosing schedule of the drug to the user; providing a trainer device to the user, the device having a dummy housing and dummy actuators similar in shape and size as the actual patch type drug delivery pump, the dummy housing containing a processor and memory coupled to respective switches of the dummy actuators; furnishing the user with a dosing schedule; actuating the dummy actuators; recording activation of the switches for the simulated actuators and the time at which such activation occurred into the memory to provide a record of training dosage events; and outputting the record to provide for a comparison between training usages of the trainer device as compared to the dosing schedule.
 10. The method of claim 9, further comprising: comparing a time at which actuating of the simulated actuators is taking place and the time prescribed by the dosing schedule; in the event at which the time prescribed in the dosing schedule is not within a predetermined time period of the actuating step, recording noncompliance of the dosing schedule in the memory; or in the event at which the prescribed time for dosing is within a predetermined time period of the actuating step, recording a compliance with the dosing schedule in the memory.
 11. The method of claim 10, in which the recording of an error comprises annunciating a negative feedback to the user at the time the recording is made.
 12. The method of claim 9, in which the recording of the compliance comprises annunciating of a positive feedback to the user at the time the recording is made.
 13. The method of claim 9, in which the outputting comprises displaying a graphical representation of time at which one or more actuations have occurred and the prescribed dose at the prescribed time.
 14. A method of training a user on the use of an actual patch type drug delivery pump configured to deliver a drug stored in the pump body, the method comprising the steps of: providing a dosing schedule of the drug to the user; providing a trainer device to the user, the device having a simulated housing and simulated actuators similar in shape and size as the actual patch type drug delivery pump, the simulated housing containing a processor and memory coupled to respective switches of the simulated actuators; annunciating to the user the dosing schedule; recording activation of the switches for the simulated actuators and the time at which such activation occurred into the memory to provide a record of training dosage events; and outputting the record to provide for a comparison between training usages of the trainer device as compared to the dosing schedule.
 15. The method of claim 14, in which the predetermined time period comprises any time period from about 10 minutes to about 60 minutes.
 16. The method of claim 14, in which the steps of recording and outputting are completed within one hour.
 17. The method of claim 14, in which the steps of recording and outputting are completed within 45 minutes.
 18. The method of claim 14, in which the steps of recording and outputting are completed within 30 minutes.
 19. The method of claim 14, in which the steps of annunciating, recording and outputting are completed within one hour.
 20. The method of claim 14, in which the steps of annunciating, recording and outputting are completed within 45 minutes.
 21. The method of claim 14, in which the steps of annunciating, recording and outputting are completed within 30 minutes. 